ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERIL

FDA device recall Z-3259-2011 · posted 2011-09-16 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.

Action taken

The firm ANGIODYNAMICS, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2011 to the consignees via Certified Mail, Return Receipt Requested. The letter described the product, problem and action to be taken. The customers were instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. The letter also instructed the consignees to (1.) Identify and segregate the recalled lot that is in your possession, (2.) Complete the enclosed Soft-Vu Angiographic Catheter Recall Reply Form and fax it to the attention of the Soft-Vu Angiographic Catheter Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number XXXXXXXXXX on the outside of the shipping box and include a copy of the Soft-Vu Angiographic Catheter Recall Reply Form with your shipment. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to customerservice@angiodynamics.com.

Root cause

Employee error

Status

Terminated

Product code

DQO

Quantity affected

Domestic - 25 units; Foreign - 5 units

Distribution

Worldwide distribution: USA (nationwide) including states of: California, Tennessee, and Wisconsin, and country of: Spain.

Date initiated

2011-06-07

Date posted

2011-09-16

Date terminated

2012-10-18

Location

Latham, NY

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